BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 83 PLUS

    MDR report key: 3417717 · Received October 11, 2013

    Report

    Report Number
    2523209-2013-00014
    Event Type
    Injury
    Date Received
    October 11, 2013
    Date of Event
    October 4, 2013
    Report Date
    October 4, 2013
    Manufacturer
    CUSTOM ULTRASONICS INC.
    Product Code
    KOG
    PMA / PMN Number
    K903817
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO TIME LINE ASSOCIATED WITH THIS EVENT, THE DEVICE HAS NOT YET BEEN EVALUATED. CUSTOM ULTRASONICS INC SCHEDULED AND WILL DISPATCH SERVICE TECHNICIANS TO THE FACILITY ON (B)(6) AND (B)(6) TO INVESTIGATE THIS INCIDENT. A FOLLOW UP REPORT WILL BE PROVIDED UPON COMPLETION. CUSTOM ULTRASONICS INC IS REPORTING THIS EVENT WITH AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SIGNS OF CARBAPENEM RESISTANT ENTEROBACTERIACEA-E.COLI METALLO BETA LACTAMASE WERE FOUND ON TWO OF THE FOUR PENTAX MODEL ED 3490TK ENDOSCOPE USED AT THEIR FACILITY. THIS WAS CONFIRMED BY TESTING AT THE CENTER FOR DISEASE CONTROL. THE CUSTOMER DOES NOT KNOW HOW THE INCIDENT OCCURRED. THEY FOUND SEVERAL PATIENTS OVER A PERIOD OF TIME WITH THIS ORGANISM AND WAS ABLE TO TRACE IT BACK TO THE SCOPE USED BY THEIR FACILITY. THE FACILITY TESTED THE SYSTEM 83 PLUS FOR THIS ORGANISM, THE RESULTS WERE NEGATIVE. (B)(6) HOSPITAL NOTIFIED 131 PEOPLE OF THE INCIDENT, TO DATE, 20 PEOPLE TESTED POSITIVE, 9 PATIENTS EXPERIENCED INFECTION OF SOME SORT ATTRIBUTED TO THE EXPOSURE OF THIS ORGANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522819 SYSTEM 83 PLUS ENDOSCOPE WASHER-DISINFECTOR KOG CUSTOM ULTRASONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other